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Drug Safety and Availability

Editor's Note - Volume 1, Number 2, Winter 2008

In each issue of the DSN, we highlight safety issues related to a diverse group of FDA-approved drug products based on our assessment of the importance and timeliness of these topics to patient care and the seriousness of the adverse events. We also provide a list of recent advisories on drug safety, with related links, that have been posted on FDA's Web site.

In this issue, an article on TNF-alpha antagonists summarizes our postmarketing reviews of cases of rare but serious skin reactions (erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis) associated with infliximab (Remicade), etanercept (Enbrel), and adalimumab (Humira). This novel class of drugs is approved for and increasingly used to treat inflammatory and autoimmune diseases including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

The second article describes the occurrence of sudden sensorineural hearing loss associated with the use of phosphodiesterase type 5 inhibitors, sildenafil citrate (Viagra), vardenafil hydrochloride (Levitra) and tadalafil (Cialis) approved for treatment of erectile dysfunction. Sildenafil citrate marketed as Revatio is also approved for treatment of pulmonary arterial hypertension.

The exenatide (Byetta) article describes cases of acute pancreatitis, a serious and potentially life-threatening adverse event. Exenatide is the first product in a new class of drugs known as incretin mimetics and is approved for the treatment of type 2 diabetes mellitus.

Also in this issue, we offer an overview of reported adverse events of interest associated with use of the new molecular entity , duloxetine (Cymbalta), a serotonin and norepinephrine reuptake inhibitor . Duloxetine is used to treat major depression, diabetic peripheral neuropathic pain, and generalized anxiety disorder in the United States.

Finally, we present our first feature article on pharmacogenomics as it relates to the potential clinical implications of this emerging science on the future of drug safety. Our evolving understanding of the pharmacogenomic variability of individual responses to drugs increases the potential to target therapies to those patients likely to get the greatest benefit as well as avoid treatment in those patients at greatest risk of adverse events.

In 2007, FDA has made available free, electronic access to a variety of clinically useful information resources for healthcare professionals at the point of care including:

We hope that healthcare providers find this newsletter a valuable complement to their clinical practices and an aid in the decision-making process for their patients.

Renan A. Bonnel, PharmD, MPH
Senior Scientific Editor


Page created: March 18, 2008; updated June 12, 2008